MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL AP PC STEM 10 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	113010200
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Der states that the global ap stem was assembled using the fix 135 neck angle.The surgeon noticed after it was implanted that the head sat proud.It was removed and disassembled.Using the same stem they converted it to a variable angle and the was prepared as per technique but did not match the trial implant.The size 10 stem was replaced with the new stem and used the variable angle again.There was a surgical delay of 20 minutes.Doe:(b)(6) 2018 right shoulder.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Examination of the returned device did not find any evidence of product error.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL AP PC STEM 10 MM
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7312953
• Report Number: 1818910-2018-54534
• Device Sequence Number: 19201492
• Product Code: KWS
• UDI-Device Identifier: 10603295005513
• UDI-Public: 10603295005513
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 113010200
• Device Lot Number: HD7358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 12/03/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 04/23/2018; 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR